BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 2802688 · Received October 24, 2012

    Report

    Report Number
    3007566237-2012-02500
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT¿S POCKET WAS TIGHTENED UP ONCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD LOST A LOT OF WEIGHT. THE PUMP WAS LOOSE; IT MOVED AND FLIPPED IN THE POCKET. THE PATIENT EXPERIENCED DIFFICULTY WITH REFILLS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1